NCT01647685: DELIVER

A Proof of Concept Study to Determine the Local Delivery and Efficacy of Intravenously Injected PEG-liposomal Prednisolone Sodium Phosphate (Nanocort) in Atherosclerotic Tissue in Subjects With Peripheral Artery Disease.

Status unknown Phase 1/Phase 2 Last updated 19 July 2012

What this trial tests

Phase 1/Phase 2 trial testing Nanocort in Atherosclerosis in 21 participants. Status unknown.

Timeline

1 May 2012

Primary endpoint
1 May 2013

1 May 2013

Quick facts

Lead sponsor	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Phase	Phase 1/Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Enrollment	21
Start date	1 May 2012
Primary completion	1 May 2013
Estimated completion	1 May 2013
Sites	1 location across Netherlands

Drugs / interventions tested

• Nanocort — full drug profile →
• Methylprednisolone (methylprednisolone) — full drug profile →
• Placebo

Conditions studied

• Atherosclerosis — all drugs for Atherosclerosis →

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) — full company profile →

Who can join

18 and older, any sex, with Atherosclerosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Quantity of PEG liposomes in the atherosclerotic plaque and/ or in atherosclerotic macrophages as determined with a PEG antibody quantitative sandwich ELISA.
  Time frame: Participation of patient: maximally 12 days (infusion 1 on day-10 (+/-2days), infusion 2 on day-3, operation and sample collection on day 0) Data assessment: average 4 months.
  Quantity of PEG liposomes in the atherosclerotic plaque and/ or in atherosclerotic macrophages as determined with a PEG antibody quantitative sandwich ELISA.

Sponsor's own description

A promising strategy to reduce CVD is to directly target inflammation at the level of the vessel wall. A potential drawback of anti-inflammatory strategies pertains to the thin line between inhibiting 'inappropriate' inflammation versus inducing immuno-suppression. One of the strategies to limit systemic immunosuppression is to strive for local delivery and prolonged efficacy and low systemic burden of the drug by encapsulating the compound in liposomes.

Liposome-encapsulated drugs efficiently target lesions and accumulate at a much higher extent at desired areas of interest. Thus, local delivery and prolonged efficacy can be very important tools to overcome the potential drawback anti-inflammatory drugs; namely an inappropriate immune suppression. In the present project, the investigators therefore aim to evaluate the delivery and superior efficacy of Nanocort above Prednison or placebo in patients with peripheral artery disease due to atherosclerosis. Because these patients will undergo an endarteriectomy the investigators will be able to collect atherosclerotic material after drug administration and thus evaluate the local delivery and compare the effects of Nanocort to Prednison or Placebo.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Design of therapeutic biomaterials to control inflammation.
   Tu Z, Zhong Y, Hu H, Shao D, et al · · 2022 · cited 314× · PMID 35251702 · DOI 10.1038/s41578-022-00426-z
2. Imaging and nanomedicine in inflammatory atherosclerosis.
   Mulder WJ, Jaffer FA, Fayad ZA, Nahrendorf M. · · 2014 · cited 147× · PMID 24898749 · DOI 10.1126/scitranslmed.3005101
3. Prednisolone-containing liposomes accumulate in human atherosclerotic macrophages upon intravenous administration.
   van der Valk FM, van Wijk DF, Lobatto ME, Verberne HJ, et al · · 2015 · cited 114× · PMID 25791806 · DOI 10.1016/j.nano.2015.02.021
4. "Eat me" imaging and therapy.
   Bagalkot V, Deiuliis JA, Rajagopalan S, Maiseyeu A. · · 2016 · cited 37× · PMID 26826436 · DOI 10.1016/j.addr.2016.01.009
5. Pharmaceutical development and preclinical evaluation of a GMP-grade anti-inflammatory nanotherapy.
   Lobatto ME, Calcagno C, Otten MJ, Millon A, et al · · 2015 · cited 34× · PMID 25791805 · DOI 10.1016/j.nano.2015.02.020
6. Biomimetic nanomedicines for precise atherosclerosis theranostics.
   Tao Y, Lan X, Zhang Y, Fu C, et al · · 2023 · cited 32× · PMID 37969739 · DOI 10.1016/j.apsb.2022.11.014
7. Advancements in dual-targeting nanoparticle strategies for enhanced atherosclerosis therapy: Overcoming limitations of single-targeting approaches.
   Yang C, Mo L, Zhang G, Dai Y, et al · · 2026 · cited 3× · PMID 41069764 · DOI 10.1016/j.bioactmat.2025.09.023
8. Lipid-based nanosystems for atherosclerosis treatment: Evolving approaches and novel therapeutic strategies.
   Li L, Guo M, Wang Z, Yu M, et al · · 2026 · cited 2× · PMID 42039292 · DOI 10.1016/j.apsb.2025.11.001